Bent Passing Needle Kit
2 catalogue numbers from BPNK1-10X, listed by AD-Tech Medical Instrument Corp., United States, under Passer. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
| Dongguan Senmed Medical Instrument Co., Ltd. | Dongguar | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | AD-Tech Medical Instrument Corp., United States |
|---|---|
| FDA product code | HWQ |
| Device type | Passer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-09 |
| Record revised | 2023-08-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: To be stored and used within typical hospital/office room ambient temperature and humidity conditions |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BPNK1-10X | In distribution | |
| BPNK2-10X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex | Provision | 76 |
| Medline | Medline Industries, Inc. | 32 |
| Conmed/Linvatec | Provision | 24 |
| Stryker | Provision | 22 |
| Cylox ST | Signus Medizintechnik Gmbh | 16 |
| Apex | Stryker GmbH | 16 |
| EZ Pass | Biomet Orthopedics | 14 |
| Passer | Smith & Nephew, Inc. | 13 |
| gSource | Gsource, LLC. | 12 |
| Millennium | Avalign Technologies, Inc. | 11 |
| Medline Renewal | Medline Industries, Inc. | 9 |
| EZPass™ | Biomet Orthopedics | 7 |
Showing 12 of 130. All products under Passer
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.